Brief Summary

The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Nov 2021

Shorter than P25 for phase_2

Geographic Reach

1 country

7 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

September 17, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed

1.2 years until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed

Last Updated

September 29, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

September 17, 2020

Last Update Submit

September 28, 2021

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Day 14

Secondary Outcomes (6)

Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Day 14
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Day 14
Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT.
Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase
Through Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to EOT.
Week 25/EOT
+1 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

ABT weekly and 3BNC117 bi-weekly

Drug: AlbuvirtideDrug: 3BNC117 Antibody

Group B

EXPERIMENTAL

both ABT and 3BNC117 treatment bi-weekly

Drug: AlbuvirtideDrug: 3BNC117 Antibody

Interventions

AlbuvirtideDRUG

Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)

Also known as: ABT

Group AGroup B

3BNC117 AntibodyDRUG

Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120

Also known as: 3BNC117

Group AGroup B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Males and females, age ≥ 18 years;
HIV-1 seropositive with documented HIV-1 infection by official, signed, written history (e.g. Laboratory report)
Receiving a combination antiretroviral therapy (cART) (failing regimen) for at least 8 weeks before Screening and are willing to continue on the failing regimen during the Screening Phase and up to Day 14 of the Treatment Phase, OR have failed in the past 8 weeks of Screening, are off therapy and are willing to stay off therapy until Day 14 of the Treatment Phase;
Plasma HIV-1 RNA ≥ 1000 copies/mL at the Screening Visit and documented detectable viral load (HIV-1 RNA \>200 copies/ml) within the last 3 months prior to the Screening Visit;
Highly treatment-experienced HIV-infected patients with genotypic and/or phenotypic resistance to at least one ARV drug for each of three or more drug classes of antiretroviral medications at the Screening Visit and have difficulty in constructing a viable suppressive regimen;
Have full viral sensitivity/susceptibility to at least one approved antiretroviral agent, other than ABT and 3BNC117, as determined by genotypic and/or phenotypic ARV drug resistance tests at screening, and such agent can be used as a component of OBR;
Be willing to remain on treatment without any changes or additions to the OBR regimen, except for toxicity management or upon meeting criteria for treatment failure;
Have a life expectancy that is \> 9 months;
Laboratory values at Screening of:
Absolute neutrophil count (ANC) ≥ 750/mm3;
Hemoglobin (Hb) ≥ 10.5 gm/dL (male) or ≥ 9.5 gm/dL (female);
Platelets ≥ 75,000 /mm3;
Serum alanine transaminase (SGPT/ALT) \< 1.25 x upper limit of normal (ULN);
Serum aspartate transaminase (SGOT/AST) \< 1.25 x ULN;
Serum total bilirubin within normal range; and
+5 more criteria

You may not qualify if:

Subject having ≥0.5 log10 reduction in HIV-1 RNA viral load from the Screening Visit to Baseline Visit (Day 0).
Note: This criterion will be evaluated prior to randomization at T1 Visit (Day 7).
Any active infection or malignancy requiring acute therapy;
Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg);
Hepatitis C infection as manifest by positive anti-HCV antibody and positive HCV RNA assay at the time of screening;
Grade 4 DAIDS laboratory abnormality;
Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study;
Unexplained fever or clinically significant illness within 1 week prior to the first study dose;
Any vaccination within 2 weeks prior to the first study dose;
Prior exposure to albuvirtide or 3BNC117
Subjects weighing \<35kg;
History of anaphylaxis to any oral or parenteral drugs;
Use of any fusion inhibitors (T20) and broadly neutralizing monoclonal antibody prior to the Screening Visit, including the investigational drugs, or having documented genotypic and/or phenotypic resistance to fusion inhibitors;
Participation in an experimental drug trial(s) within 30 days of the Screening Visit;
Any known allergy or antibodies to the study drug or excipients;
+6 more criteria

Contact the study team to confirm eligibility.